Medline Incision and Drainage Tray Recalled for Subpotent Iodine
Medline is recalling Incision and Drainage Trays because the Povidone-Iodine prep pads contain less iodine than labeled.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving subpotent drugs where efficacy is compromised.
Plain-English summary
Medline Industries Inc. is recalling 2,369 cases of Medline Incision and Drainage Tray, Sterile, Single Use Only. The product was packaged in Mexico by Medline Industries, Inc., in Mundelein, IL.
The recall was initiated because the titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%. This is classified as a subpotent drug issue.
The affected products were distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey. The specific pack numbers are DYNJ07147 and DYNJ07147H, associated with lots 1160B1635, 17RB8957, 16WB2198, 16GB6023, 16KB1547, and 17DB1855. Consumers and healthcare providers should check their inventory for these specific lot and pack numbers and stop using the product if it matches the recall description.
The recalled product
- Product
- Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Trays
- Affected units
- 2,369
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Pack Number: DYNJ07147
- Lots 1160B1635
- 17RB8957
- 16WB2198
- 16GB6023
- 16KB1547
- 17DB1855 Pack Number: DYNJ07147H
- Lots 17DB1855
Distribution
Part of a larger recall action
This product is one of 68 recalled by Medline Industries Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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